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Sanofi (SNY) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
Sanofi · no upcoming catalyst on file · 7 past FDA decisions

FDA decision history (7)

Apr 22, 2026✓ ApprovedFDA decisionFeb 24, 2026✓ ApprovedFDA decisionDec 28, 2025✕ CRLFDA decisionAug 29, 2025✓ ApprovedFDA decisionJun 2, 2025✓ ApprovedFDA decisionApr 18, 2025✓ ApprovedFDA decisionMar 28, 2025✓ ApprovedFDA decision

Clinical readouts (3)

2026-12Rilzabrutinib2026-11Rilzabrutinib2026-10Venglustat
Full PDUFA calendar →All FDA decisions →Phase readouts →
See the full 2026 PDUFA calendar →

This page aggregates SNY's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.

SNY run-up, measured

Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.

SNY's past FDA decisions (n=30)
DecisionOutcomeT-120 to eveT-120 to peak
2026-04-22APPROVAL-8.3%+1.8%
2026-02-24APPROVAL-4.6%+5.8%
2025-12-28CRL+0.6%+8.6%
2025-08-29APPROVAL-15.7%+0.2%
2025-06-02APPROVAL+2.8%+23.8%
2025-04-18APPROVAL-3.8%+12.3%
2025-03-28APPROVAL-2.4%+5.6%
2024-12-17APPROVAL-5.0%+21.1%
2024-09-20APPROVAL+19.9%+20.4%
2024-07-18APPROVAL+0.6%+2.9%
2024-06-11APPROVAL+2.5%+10.1%
2024-01-25APPROVAL-3.1%+7.2%
Showing the 12 most recent of 30.
Median across these 30 decisions: -2.4% from T-120 to the eve, +8.7% to the peak. A median over 30 events describes this stock's past only. It is not a forecast, and the cohort figures on the run-up study are the larger statistical base.

Common questions

When is the next FDA decision or readout for Sanofi (SNY)?

October 2026. The next catalyst for Sanofi is Venglustat (readout). That date is known to the month only. 2 further catalysts are scheduled after it. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.

Has Sanofi (SNY) had an FDA decision before?

Yes, 7 in our archive: 6 approval(s) and 1 Complete Response Letter(s). The most recent was on April 22, 2026 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.

How has SNY stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Median across these 30 decisions: -2.4% from T-120 to the eve, +8.7% to the peak. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.

Where does this SNY data come from?

FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.